Biomedical subjects

M Donawa

Publications and source records attributed to M Donawa.

20 records · Page 2Linked to original sources

PubMedDate not supplied

The impact of the new quality management system standards on the CE-marking process.

In December 2000, the new ISO 9000 quality management system series of standards was published. This represents a significant development for manufacturers marketing medical devices in Europe, who use these standards to demonstrate conformity to the European medical device Directives. This article discusses some issues related to the introduction of these standards in Europe and their use in the CE-marking process.

Consumer Product Safety↗

PubMedDate not supplied

Drug delivery systems: avoiding the pitfalls.

Drug delivery systems are increasingly sophisticated, sometimes in ways that make it difficult to determine the regulatory and quality system requirements for the device component of these systems. This article discusses some important requirements and factors to consider when designing, developing and marketing drug delivery systems.

Drug Delivery Systems↗